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Psychological Health and Adverse Childhood Experiences in Myasthenia Gravis: Online Mental Health BMI Learning Program

NCT ID: NCT07291713

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-01-09

Brief Summary

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This study evaluated psychological health in patients with myasthenia gravis (MG) using an online behavioral program called the "Positive Mental Health BMI Learning Program." The program consisted of four short video units focused on interpersonal support, emotional regulation, and personal meaning. Patients receiving care in the neurology outpatient clinic were invited to complete questionnaires before and after viewing the online program. Psychological well-being, depressive symptoms, daily functioning, and quality of life were assessed to describe participants' mental health status and changes observed over the course of the program.

Detailed Description

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Participants completed sociodemographic questionnaires, adverse childhood experiences (ACEs) assessments, and four psychological and disease-related measures: the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL), the Myasthenia Gravis Quality of Life 15-item scale (MG-QOL15), the mental health BMI indicator (mBMI), and the Patient Health Questionnaire-9 (PHQ-9). The study collected baseline data prior to the online program and post-intervention data after completion of the four video units. Analyses examined associations between ACE exposure and psychological measures, as well as changes in clinical and psychological indicators across the intervention period.

Conditions

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Myasthenia Gravis Adverse Childhood Experience Psychological Well-being Mental Well-being Depressive Symptoms Psychological Stress Quality of Life (QOL) Activities of Daily Living Emotional Regulation Mental Health Well-Being, Psychological

Keywords

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myasthenia gravis adverse childhood experience online learning program positive mental health BMI learning program emotional regulation emotional stability psychological well-being mental health BMI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants were enrolled into a single study group and received the same online behavioral intervention, the online Positive Mental Health BMI Learning Program. Pre-test and post-test assessments were completed by participants to measure psychological outcomes.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

This was an open-label study in which no masking was used. All participants and investigators were aware of the behavioral intervention being provided.

Study Groups

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Intervention Group

All participants were assigned to a single intervention arm and received the Positive Mental Health BMI Learning Program. This program consisted of four pre-recorded online video units delivered over four months through a closed Facebook group. The units covered interpersonal support, emotional regulation, and self-worth and meaning. Participants completed pre-test assessments before beginning the program and post-test assessments after completing all four units.

Group Type EXPERIMENTAL

Positive Mental Health BMI Learning Program

Intervention Type BEHAVIORAL

The intervention consisted of the Positive Mental Health BMI Learning Program, a four-unit online behavioral program delivered through a closed Facebook group. Each video unit was approximately 15 minutes and focused on components of positive mental health, including interpersonal support, emotional regulation, and sense of meaning and self-worth. One unit was released each month over a four-month period. Participants completed pre-test assessments before the program and post-test assessments after completing all four units.

Interventions

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Positive Mental Health BMI Learning Program

The intervention consisted of the Positive Mental Health BMI Learning Program, a four-unit online behavioral program delivered through a closed Facebook group. Each video unit was approximately 15 minutes and focused on components of positive mental health, including interpersonal support, emotional regulation, and sense of meaning and self-worth. One unit was released each month over a four-month period. Participants completed pre-test assessments before the program and post-test assessments after completing all four units.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with a confirmed diagnosis of myasthenia gravis (MG) based on acetylcholine receptor antibody testing, single-fiber electromyography, repetitive nerve stimulation, or chest computed tomography.
* Individuals able to clearly express their own intentions.
* Individuals without cognitive impairment or psychiatric disorders.
* Individuals who are able to use Facebook and who agree to participate in the study and provide written informed consent.

Exclusion Criteria

* Individuals who do not have a diagnosis of MG.
* Patients who are unable to communicate adequately in Mandarin, Taiwanese, English, or written form.
* Individuals with head trauma, psychiatric symptoms, or cognitive impairment that may interfere with verbal expression.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiann-Horng Yeh

OTHER

Sponsor Role lead

Responsible Party

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Jiann-Horng Yeh

Vice Superintendent, Professor of Neurology, Shin Kong Wu Ho-Su Memorial Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jiann-Horng Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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Liu, S. M. (2020). The Study of Cut-off Scores for Mental Health BMI Index. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taipei University of Nursing and Health Sciences. Available at: https://hdl.handle.net/11296/p992dy

Reference Type BACKGROUND

Li, Y. C. (2019). The Cluster Analysis of the Positive and Negative Indicators of Complete Mental Health State Model. Special Research of the Ministry of Science and Technology (MOST 108-2637-H-227-001). Available at: https://www.airitilibrary.com/Article/Detail?DocID=U0068-0309202111314000

Reference Type BACKGROUND

Li, Y. C. and Chen, Y. F. (2016). National mental health BMI. Couns. Guid. 369, 50-55. doi: 10.6251/bep.202406_55(4).0008

Reference Type BACKGROUND

Li, Y. C., Fang, C. K., Liu, C. Y., and Chang, W. H. (2024). Cluster Analysis of the Positive and Negative Indicators of Complete Mental Health State Model. Chinese Journal of Guidance and Counseling, 69, 37-75. Chin. J. Guid. Couns. 69, 37-75. doi: 10.53106/172851862024010069002

Reference Type BACKGROUND

Harris, N. B. (2018). The Deepest Well: Healing the Long-Term Effects of Childhood Adversity. New York, NY: Houghton Mifflin Harcourt. ISBN-13: 978-0544828704

Reference Type BACKGROUND

Chiu, T. Y. (2021). Effect of Promoting Positive Mental Health BMI by Group Counseling for Myasthenia Gravis. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taipei University of Nursing and Health Sciences. Available at: https://hdl.handle.net/11296/62vwcp

Reference Type BACKGROUND

Chung, M. Y. (2018). Building Mental Health BMI Indicator on Well-Being: A Sampling from Myasthenia Gravis Patients. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taipei University of Nursing and Health Sciences. Available at: https://hdl.handle.net/11296/st3u9u

Reference Type BACKGROUND

Chen, Y. J. (2023). The relationships among adverse childhood experiences, resilience, and health status in patients with ankylosing spondylitis. [master's thesis]. [Taichung (Taiwan, R.O.C.)]: Chung Shan Medical University. Available at: https://hdl.handle.net/11296/d55q94

Reference Type BACKGROUND

Liao, C. M. (2022). A Relational Research on Personality Traits, Resilience, and Career Self-Efficacy among Adults with Adverse Childhood Experiences. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taiwan Normal University. Available at: https://hdl.handle.net/11296/p3359x

Reference Type BACKGROUND

Huang, C. C. (2017). A Study on the Childhood Adversity Experiences and Resilience. [master's thesis]. [Kaohsiung (Taiwan, R.O.C.)]: Shu-Te University. Available at: https://hdl.handle.net/11296/d383p6

Reference Type BACKGROUND

Bellis MA, Hughes K, Ford K, Butler N, Wilson C, Quigg Z. Relative and combined contributions of adverse childhood experiences and self-reported child poverty to health and economic outcomes in adults - a retrospective study in a UK region. BMC Public Health. 2025 Oct 15;25(1):3501. doi: 10.1186/s12889-025-23938-z.

Reference Type BACKGROUND
PMID: 41094458 (View on PubMed)

Bunting L, Davidson G, McCartan C, Hanratty J, Bywaters P, Mason W, Steils N. The association between child maltreatment and adult poverty - A systematic review of longitudinal research. Child Abuse Negl. 2018 Mar;77:121-133. doi: 10.1016/j.chiabu.2017.12.022. Epub 2018 Jan 12.

Reference Type BACKGROUND
PMID: 29346067 (View on PubMed)

Liu SI, Yeh ZT, Huang HC, Sun FJ, Tjung JJ, Hwang LC, Shih YH, Yeh AW. Validation of Patient Health Questionnaire for depression screening among primary care patients in Taiwan. Compr Psychiatry. 2011 Jan-Feb;52(1):96-101. doi: 10.1016/j.comppsych.2010.04.013. Epub 2010 Jul 1.

Reference Type BACKGROUND
PMID: 21111406 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Burns TM, Conaway MR, Cutter GR, Sanders DB; Muscle Study Group. Less is more, or almost as much: a 15-item quality-of-life instrument for myasthenia gravis. Muscle Nerve. 2008 Aug;38(2):957-63. doi: 10.1002/mus.21053.

Reference Type BACKGROUND
PMID: 18642357 (View on PubMed)

Mullins LL, Carpentier MY, Paul RH, Sanders DB; Muscle Study Group. Disease-specific measure of quality of life for myasthenia gravis. Muscle Nerve. 2008 Aug;38(2):947-56. doi: 10.1002/mus.21016.

Reference Type BACKGROUND
PMID: 18697209 (View on PubMed)

Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999 Apr 22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.

Reference Type BACKGROUND
PMID: 10227640 (View on PubMed)

Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

Reference Type BACKGROUND
PMID: 9635069 (View on PubMed)

Other Identifiers

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20230731R

Identifier Type: -

Identifier Source: org_study_id